18 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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T2 RECON NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032898·Baltic Denture System BDLoad Ln6 PLSEbil2DFl B3...
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ST. JOSEPH HSP BALTIMORE MD1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010
EMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 29, 2011
LIFESHIELD CONV SOLUSET
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPK·April 23, 2008
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
SMART, PERFUSION PACKS, CONNECTORS, TUBING
FDA Adverse Event
Malfunction
·LIVANOVA USA·Product code DWE·August 1, 2023
CSC14 CARDIOLOGIA HEAT EXCHANGER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·March 10, 2016
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTR·November 20, 2015
CSC14 BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019
CHILDRENS MERCY KS CITY MO1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024